AzTrials
AzTrials

Haematological AbnormalityPhase 1/2NCT01936064

The Safety and Efficacy of Jobelyn in the Treatment of Breast Cancer Patients

A Phase 1/2 study testing Jobelyn + Cyclophosphamide-Epirubicin6 in people with Haematological Abnormality, run by Lagos State University at 2 sites in Nigeria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

To determine the effective functionality/potency of Jobelyn as an immunologic and haematologic booster in Breast cancer patients (start-off), thus improving the outlook and the quality of life of such patients generally Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Haematological Abnormality
What is being tested?
Jobelyn + Cyclophosphamide-Epirubicin6
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
2 sitesNigeria
Study dates
Oct 2016to Jan 2018
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Women with histologically confirmed breast cancer who had undergone complete or segmental mastectomy plus axillary node dissection were included

Who cannot join

  • Patients were excluded if they had distant metastases residual disease in the breast or axilla other serious medical illnesses, or a previous cancer. Women considering pregnancy or using hormones were excluded
  • Patients who refuse to sign consent form

Trial locations and contacts

2 sites in 1 country.

Abiodun Popoola, M.D. contact

2348033021434

pabiodun2001@yahoo.com

Nigeria2 sites, 2 recruiting
  • Lagos State University Teaching Hospital

    Ikeja, Lagos, 100001

    Abiodun Popoola, M.D., 2348033021434, okubena@health-forever.com

    Abiodun Popoola, M.D.

    Recruiting
  • Lagos State University

    Ikeja, Lagos, 100001

    Abiodun Popoola, M.D., 2348033021434, pabiodun2001@yahoo.com

    A. O. Dosunmu, M.D.

    Recruiting

Other trials in Nigeria

About this study

Official title: A Prospective Phase II Randomized, Blinded Study to Demonstrate the Effectiveness of Jobelyn for the Treatment of Breast Cancer Patients.

To determine the effective functionality/potency of Jobelyn as an immunologic and haematologic booster in Breast cancer patients (start-off), thus improving the outlook and the quality of life of such patients generally

Read the detailed description

Breast cancer is one of the most frequent malignant tumor of women in Nigeria. In Nigeria, among the urban women, the numbers of breast cancer patients were increasing annually, both to aging of the population and increase in age-specific incidences. Case control studies in parts of the country have identified the factors such as null parity, late age at marriage, and late age at first pregnancy are important risk factors. It has also been suggested that western dietary influences changed the lifestyle of urban women could be one of the major causes of the slowly rising incidence of breast cancer in Nigeria. Therefore early detection and search for potential anti-tumour compounds are important in the control of breast cancer.Standard treatment modalities have improved the overall outlook and quality of life for women with breast cancer; however, the fact that more than 50% still succumb to disease highlights the need for new therapeutic approaches and identification of new therapeutic targets.

Jobelyn is made from Sorghum bicolor which grows abundantly in many parts of the world. Major component analysis of the raw materials and the finished product showed that the herbal product contains oligomeric and polymeric proanthocyanidin (OPCs) which are a class of flavonoid complexes. They are also referred to as condensed tannins. They were first discovered in 1948 by Jacques Masquelier, who developed and later patented techniques for the extraction of proanthocyanidin from pine needles and grape seeds. They can also be found in apples, coconut, cocoa beans, black currant, green tea, black tea. Cocoa beans contain the highest concentrations.

In preliminary research, proanthocyanidin was reported to have anti-mutagenic activity. Studies also show that proanthocyanidin antioxidant capabilities are 20 times more powerful than vitamin C and 50 times more potent than vitamin E2. They also work directly to help strengthen all the blood vessels and improve the delivery of oxygen to the cells. Having affinity for cell membranes, they provide nutritional support to reduce capillary permeability and fragility. These they owe to their role in stabilization of collagen and maintenance of elastin.

Oligomeric proanthocyanidin helps in cancer treatment by inhibiting the initiation and progress of cancer cells. This is why according to a study, it was found that Jobelyn water extract had a stronger effect on increasing Cluster of Differentiation 69 expression in Natural Killer cells (higher cytotoxic activity) while Jobelyn Ethyl Alcohol extract had the greatest effect on increasing Cluster of Differentiation 69 expression in Natural Killer T-cells, T-cells and monocytes (activation \& proliferation). In addition to its selective cytotoxicity property, oligomeric proanthocyanidin may up-regulate certain apoptosis promoter genes and down-regulate apoptosis-inhibitor genes in cancerous cells.

3-Deoxyanthocyanidins are a rare type of flavonoids restricted to a few plant species. They are the major pigments in flowers of sinningia (Sinningia cardinalis) and are found in silk tissues of certain maize lines. Sorghum is the only dietary source for 3-deoxyanthocyanidins, which are present in large quantities in the bran of some cultivars . Many plants use secondary metabolites to protect themselves against pathogen attack. In sorghum, this defense response is an active process resulting in the accumulation of high levels of 3-deoxyanthocyanidin phytoalexins in infected tissues. Luteolinidin and apigeninidin are the two major 3-deoxyanthocyanidins. Flavonoids are increasingly recognized for their range of health benefits, such as reducing the risks of cardiovascular diseases and cancers due to their antioxidant, anti-inflammatory, and chemoprotective properties. In particular, anthocyanins and anthocyanidins from different sources were shown to suppress proliferation and induce apoptosis in cancer cell lines. In a recent study, 3-deoxyanthocyanidins were found to have antioxidant properties similar to those of anthocyanins, but they are more stable to power of hydrogen, temperature, and light changes,suggesting that they could serve as an alternative source of natural pigments with nutraceutical properties.

The unique properties of 3-deoxyanthocyanidins may extend to their biochemical activity as well. For example, Shih et al. recently demonstrated that the major sorghum 3-deoxyanthocyanidins aglycons, apigeninidin and luteolinidin, were more cytotoxic to human cancer cells than their anthocyanidin analogues, cyanidin and pelargonidin

Recent research publication confirmed that the variety of Sorghum bicolor from which Jobelyn was produced contained two unique compounds which are being reported for the first time in Sorghum and in nature and these compounds have been tested in vitro for their anti-inflammatory properties using Ibuprofen as control. They showed superior results to Ibuprofen for their safety and efficacy properties. Hitherto, 3-deoxyanthocyanidins which have been known to contain two main compounds, apigeninidin and luteolinidin has now been increased to four compounds, courtesy of the two new additions discovered from the unique Sorghum variety which is the main ingredient of Jobelyn.

Anaemia, commonly defined as a haemoglobin level of <14g/dl in men and <12g/dl in women, occurs in over 30% of cancer patients at any point in time, and its incidence increases with treatment and disease progression. This anaemia could be related to the patient (haemoglobinopathies, gastrointestinal problems, thalassemia, etc.), related to the disease (bone marrow infiltration, bowel resection, hypersplenism, diminished nutritional state) or related to therapy (drug-induced haemolysis, hypoplasia of bone marrow-bearing areas such as the pelvis secondary to radiotherapy, bone marrow and renal toxicity secondary to chemotherapy, etc.). Inflammatory cytokines such as tumour necrotic factor-alpha and interleukin-6, among others, play a major role in the pathophysiology of anaemia in the cancer patient, not only through complex mechanisms of the purely inflammatory situation but also through genetic regulatory aspects of erythropoiesis.

Oxidative stress brought about by overwhelming of the body by free radicals from the disease itself (cancer) and the therapy both contribute to increased haemolysis and immune depression, as these degrade cell linings and disrupt many biochemical pathways. Jobelyn, which contains majorly oligomeric proanthocyanidin, prevent cell membrane damage by disrupting the biochemical formation of free radicals, thus preventing the release of haemolytic inflammatory cytokines.

In tandem, by mopping up free radicals, it would be found useful in delaying the onset of opportunistic infection in cancer patients, which in itself can provoke further haemolysis. However, these functions are still being proven in Human Clinical Trials which has so far been carried out in two research centres in Nigeria, though primarily amongst sickle cell and HIV/AIDS patients1. However, this experimental trial is now being extended to cancer patients to assess its usefulness in this condition.

Being tested
Jobelyn + Cyclophosphamide-Epirubicin6, Placebo + Cyclophosphamide - Epirubicin 6
Keywords
Breast Cancer, Jobelyn, Sorghum bicolor
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Jobelyn + Cyclophosphamide-Epirubicin6Dietary supplement

    Also called Sorghum bicolor extract

    Jobelyn (dietary Supplement) to be used with Cyclophosphamide-Epirubicin6

  • Placebo + Cyclophosphamide - Epirubicin 6Drug

    Also called Breast Cancer drugs

    Routine drugs for the treatment of breast cancer to be used with Placebo

Study groups in NCT01936064
Study groupRoleWhat they receive
Jobelyn + Cyclophosphamide-Epirubicin6Active comparatorCyclophosphamide- Epirubicin 6 course regimen to be used with Jobelyn
Receives: Dietary Supplement: Jobelyn + Cyclophosphamide-Epirubicin6
Placebo + Cyclophosphamide- Epirubicin 6Active comparatorRoutine drugs for treatment of Breast Cancer used with Placebo
Receives: Drug: Placebo + Cyclophosphamide - Epirubicin 6

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Natural Killer Cells Expression

    Evaluation of the expression of activated natural killer cells CD3-CD56+CD69+ after treatment with Jobelyn

    Measured: 6 months

Secondary outcomes (2)
  1. Use of health related quality of life measures tool Safety Fractor-36 and self reporting questionnaires

    Subjects would use form Safety Fractor-36 to score aspects of well-being

    Measured: 6 months

  2. Hematocrit Changes

    Changes in levels of hematocrit after treatment with Jobelyn

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2013 (estimated)
  2. Study startOct 2016
  3. Primary completionOct 2017 (estimated)
  4. Study completionJan 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01936064
Sponsor's protocol ID
LASUTH/09/2012
Other IDs
HEALTH FOREVER PRODUCT LTD
Status last verified
Oct 2016
First submitted
18 May 2013
Last updated
1 Nov 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Geera B, Ojwang LO, Awika JM. New highly stable dimeric 3-deoxyanthocyanidin pigments from sorghum bicolor leaf sheath. J Food Sci. 2012 May;77(5):C566-72. doi: 10.1111/j.1750-3841.2012.02668.x. Epub 2012 Apr 10.

    PubMed 22489620
  • Brohan M, Jerkovic V, Collin S. Potentiality of red sorghum for producing stilbenoid-enriched beers with high antioxidant activity. J Agric Food Chem. 2011 Apr 27;59(8):4088-94. doi: 10.1021/jf1047755. Epub 2011 Mar 7.

    PubMed 21381750
  • Yang L, Browning JD, Awika JM. Sorghum 3-deoxyanthocyanins possess strong phase II enzyme inducer activity and cancer cell growth inhibition properties. J Agric Food Chem. 2009 Mar 11;57(5):1797-804. doi: 10.1021/jf8035066.

    PubMed 19256554
  • Kayode AP, Nout MJ, Linnemann AR, Hounhouigan JD, Berghofer E, Siebenhandl-Ehn S. Uncommonly high levels of 3-deoxyanthocyanidins and antioxidant capacity in the leaf sheaths of dye sorghum. J Agric Food Chem. 2011 Feb 23;59(4):1178-84. doi: 10.1021/jf103963t. Epub 2011 Jan 25.

    PubMed 21322653
  • Shih CH, Siu SO, Ng R, Wong E, Chiu LC, Chu IK, Lo C. Quantitative analysis of anticancer 3-deoxyanthocyanidins in infected sorghum seedlings. J Agric Food Chem. 2007 Jan 24;55(2):254-9. doi: 10.1021/jf062516t.

    PubMed 17227050
  • Camargo Filho I, Cortez DA, Ueda-Nakamura T, Nakamura CV, Dias Filho BP. Antiviral activity and mode of action of a peptide isolated from Sorghum bicolor. Phytomedicine. 2008 Mar;15(3):202-8. doi: 10.1016/j.phymed.2007.07.059. Epub 2007 Sep 24.

    PubMed 17890069
  • Burdette A, Garner PL, Mayer EP, Hargrove JL, Hartle DK, Greenspan P. Anti-inflammatory activity of select sorghum (Sorghum bicolor) brans. J Med Food. 2010 Aug;13(4):879-87. doi: 10.1089/jmf.2009.0147.

    PubMed 20673059
  • Park JH, Darvin P, Lim EJ, Joung YH, Hong DY, Park EU, Park SH, Choi SK, Moon ES, Cho BW, Park KD, Lee HK, Kim MJ, Park DS, Chung IM, Yang YM. Hwanggeumchal sorghum induces cell cycle arrest, and suppresses tumor growth and metastasis through Jak2/STAT pathways in breast cancer xenografts. PLoS One. 2012;7(7):e40531. doi: 10.1371/journal.pone.0040531. Epub 2012 Jul 6.

    PubMed 22792362
  • Wu L, Huang Z, Qin P, Yao Y, Meng X, Zou J, Zhu K, Ren G. Chemical characterization of a procyanidin-rich extract from sorghum bran and its effect on oxidative stress and tumor inhibition in vivo. J Agric Food Chem. 2011 Aug 24;59(16):8609-15. doi: 10.1021/jf2015528. Epub 2011 Jul 29.

    PubMed 21780844
  • Devi PS, Kumar MS, Das SM. Evaluation of antiproliferative activity of red sorghum bran anthocyanin on a human breast cancer cell line (mcf-7). Int J Breast Cancer. 2011;2011:891481. doi: 10.4061/2011/891481. Epub 2011 Oct 16.

    PubMed 22312562
  • Awika JM, McDonough CM, Rooney LW. Decorticating sorghum to concentrate healthy phytochemicals. J Agric Food Chem. 2005 Aug 10;53(16):6230-4. doi: 10.1021/jf0510384.

    PubMed 16076098
  • Benson KF, Beaman JL, Ou B, Okubena A, Okubena O, Jensen GS. West African Sorghum bicolor leaf sheaths have anti-inflammatory and immune-modulating properties in vitro. J Med Food. 2013 Mar;16(3):230-8. doi: 10.1089/jmf.2012.0214. Epub 2013 Jan 5.

    PubMed 23289787
  • Tayo AO, Dosunmu AO, Akinola IO, Adewunmi A, Oloyede OA, Akinbami AA, Osikomaiya BI, Makanjuola SB. An open-label, randomized, parallel-group comparative study of the efficacy of sorghum bicolor extract in preoperative anemia. Nutrition. 2017 Jan;33:113-117. doi: 10.1016/j.nut.2016.05.005. Epub 2016 May 18.

    PubMed 27461168
  • Newly isolated compounds from West African Sorghum bicolor leaf sheaths Jobelyn® show potential in cancer immunosurveillance DOI: http://dx.doi.org/10.14312/2052-4994.2016-6

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Jobelyn + Cyclophosphamide-Epirubicin6 in people with Haematological Abnormality, run by Lagos State University at 2 sites in Nigeria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Abiodun Popoola, M.D. (2348033021434, pabiodun2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Natural Killer Cells Expression (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01936064, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in